Efferalgan 500 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Efferalgan 500 mg hard capsules

paracetamol

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for use of this medicine provided in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult your doctor if your condition worsens or if fever does not improve after 3 days or pain after 5 days.

Leaflet contents

1. What Efferalgan is and what it is used for
2. What you need to know before taking Efferalgan
3. How to take Efferalgan
4. Possible side effects
5. How to store Efferalgan capsules
6. Contents of the pack and other information

1. What Efferalgan is and what it is used for

Paracetamol is an analgesic that also has antipyretic properties.

This medicine is used for the symptomatic treatment of mild to moderate occasional pain in adults and children aged 12 years and older.

You should consult your doctor if your condition worsens or if fever persists for more than 3 days or pain for more than 5 days.

2. What you need to know before taking Efferalgan

Do not take Efferalgan:

• if you are allergic (hypersensitive) to paracetamol or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

Do not take more than the recommended dose indicated in section 3, How to take Efferalgan.

• The simultaneous use of this medicine with other medicines containing paracetamol, such as cold and flu remedies, should be avoided, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• Chronic alcoholics should take care not to take more than 2 g/24 hours of paracetamol.
• Alcohol consumption is not recommended during treatment.
• Patients with chronic malnutrition, anorexia, cachexia, bulimia, or fasting should consult their doctor before taking this medicine.
• Patients with kidney, liver, heart, or lung disease, or those with anemia, should consult their doctor before taking this medicine.
• If you are being treated with antiepileptic medicines, consult your doctor before taking this medicine, because when used together, the efficacy may be reduced and the hepatotoxicity of paracetamol may be increased, especially with high-dose paracetamol treatment.
• Patients with asthma who are sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.
• Paracetamol may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and Toxic Epidermal Necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and the medicine should be discontinued at the first sign of skin rash or any other sign of hypersensitivity.
• Frequent, long-term use of analgesics may cause or worsen headaches. If you suffer from chronic headaches and have been taking analgesics for more than 3 months, at least on alternate days, you should not increase the dose of analgesics but consult your doctor.

During treatment with Efferalgan, inform your doctor immediately if:

• You have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Interference with laboratory tests

If you are due to have any laboratory tests (including blood and urine tests), inform your doctor that you are taking this medicine, as it may alter test results.

Paracetamol may alter the analytical values of uric acid and glucose.

Other medicines and Efferalgan

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

In particular, if you are taking any of the following medicines, dosage adjustments or discontinuation of treatment may be necessary:

• Medicines to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin)
• Medicines for epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medicines for tuberculosis: isoniazid, rifampicin
• Medicines for depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medicines to lower blood cholesterol levels: colestyramine
• Medicines used to increase urine elimination (loop diuretics such as furosemide)
• Medicines used in the treatment of gout: probenecid and sulfinpyrazone
• Medicines used to prevent nausea and vomiting: metoclopramide and domperidone
• Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): propranolol
• Flucloxacillin (antibiotic): due to a serious risk of blood and fluid disturbances (called metabolic acidosis with high anion gap) that requires urgent treatment (see section 2).

Taking Efferalgan with food, drinks, and alcohol

The use of paracetamol in patients who regularly consume alcohol may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy and Lactation

If you are pregnant or think you might be pregnant, consult your doctor before taking this medicine.

Paracetamol may be used during pregnancy if necessary. Use the lowest possible dose that controls pain or fever, and use it for the shortest possible duration. Contact your doctor or midwife if pain or fever does not subside, or if you need to take the medicine more frequently.

Paracetamol passes into breast milk; therefore, breastfeeding women should consult their doctor or pharmacist before taking this medicine.

Driving and Operating Machinery

The effect of paracetamol on the ability to drive and operate machinery is none or negligible.

Efferalgan contains Azorubine and Sodium

This medicine contains 0.51 mg of azorubine. This medicine may cause allergic-type reactions. It may cause asthma, particularly in patients allergic to acetylsalicylic acid.

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; hence, it is essentially "sodium-free".

3. How to take Efferalgan

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults:

1 capsule every 4–6 hours or 2 capsules every 6–8 hours as needed. Under no circumstances should you exceed 2 capsules per dose.

Do not take more than 3 grams of paracetamol in 24 hours.

Use in children and adolescents

Adolescents 12–14 years:

1 capsule every 4–6 hours as needed. Do not take more than 5 capsules in 24 hours.

Children under 12 years of age must not take this medicine.

Elderly patients:

Dosage adjustment is usually not necessary in elderly patients. However, concomitant risk factors—some of which are more common in the elderly—should be taken into account, as they may require dose adjustment.

Patients with liver disease:

Before taking this medicine, you must consult your doctor.

You should take the amount prescribed by your doctor, with a minimum interval of 8 hours between doses.

Do not take more than 4 capsules in 24 hours, divided into several doses.

Patients with kidney disease:

Before taking this medicine, you must consult your doctor.

Take a maximum of 1 capsule per dose.

Depending on your condition, your doctor will advise whether you should take the medicine at intervals of at least 6 or 8 hours.

Always take the lowest effective dose.

This medicine should only be taken when pain or fever occurs. As symptoms subside, treatment should be discontinued.

Prolonged use of high daily doses of paracetamol should be avoided, as it increases the risk of adverse effects such as liver damage.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, stop treatment and consult your doctor.

For sore throat, do not take the medicine for more than 2 consecutive days without consulting your doctor.

Method of administration

The capsules are for oral use.

They should be swallowed with a glass of liquid, preferably water.

If you take more Efferalgan than you should

Contact your doctor or pharmacist immediately.

Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

The following events have been observed after paracetamol overdose:

• Acute kidney failure.
• A disease in which small blood clots form in the bloodstream, blocking blood vessels.
• Rare cases of inflammation of the pancreas.

If an overdose has been ingested, seek immediate medical attention even if no symptoms are present, as symptoms often do not appear until 3 days after ingestion, even in cases of severe poisoning.

Treatment of overdose is most effective if started within 4 hours of taking the medicine.

Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxic effects of a paracetamol overdose.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), stating the name of the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The possible adverse effects of this medicine are:

Rare adverse effects (may affect up to 1 in 1,000 people): malaise, increased blood transaminase levels, anaphylactic reaction (including hypotension), anaphylactic shock, hypersensitivity, and angioedema.

Very rare adverse effects (may affect up to 1 in 10,000 people): kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar).

Adverse effects with unknown frequency: purpura, fixed drug eruption (red or purple skin lesion that reappears in the same location), bronchospasm (excessive and prolonged contraction of the respiratory tract muscles causing breathing difficulty), and a serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

Paracetamol may damage the liver when taken in high doses or with prolonged use.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Efferalgan

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Efferalgan

Each capsule contains 500 mg of paracetamol as the active substance.

The other components are: magnesium stearate.

Capsule components: gelatin and azorubine (E-122).

Appearance of Efferalgan and contents of the pack

Hard capsules with a translucent red cap and translucent body.

Presented in packs containing 24 capsules.

Marketing Authorization Holder

UPSA SAS

3 rue Joseph Monier

92500 Rueil-Malmaison

France

Manufacturer

UPSA

304, Avenue du Docteur Jean Bru

47000 Agen (France)

or

UPSA

979, Avenue des Pyrénées (Le Passage)

47520 - France

Local representative

NEWLINE PHARMA, S.L.U.

Calle Tarragona 151-157, 11th Floor, Door 1, Block A

08014 Barcelona (Spain)

Tel.: 931851380

Date of the most recent review of this leaflet: November 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/